UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044260 |
|---|---|
| Receipt number | R000043185 |
| Scientific Title | Development and evaluation of a cervical cancer screening training program for midwives in Japan |
| Date of disclosure of the study information | 2021/05/19 |
| Last modified on | 2021/05/19 16:08:56 |
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Basic information
Public title
Development and evaluation of a cervical cancer screening training program for midwives in Japan
Acronym
Pap smear taker training program for midwives
Scientific Title
Development and evaluation of a cervical cancer screening training program for midwives in Japan
Scientific Title:Acronym
Pap smear taker training program for midwives
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a cervical cancer screening training program and to validate the program through the number of unsatisfactory samples and women's comfort
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
number of unsatisfactory samples
evaluation by women
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Pap smear taker training program
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Mdidwives
The advanced midwives certified by CLoCMiP working for the Japanese red cross medical center or ones to be this year.
2. Women older than 30years working for the Japanese red cross medical center who come to the health center for cervical cancer screening and who give oral and written consents.
Key exclusion criteria
1.Midwives
1)not belonging to the Japanese red cross medical center.
2)Midwives not certified as advanced midwives by CLoCMiP working for the Japanese red cross medical center.
2.Among women working for the Japanese red cross medical center who receive pap smears at the health center,women
1)who do not agree to pap smears performed by trained midwives
2)in pregnancy
3)having had cervical conectomy and excluded by Ob/Gyns
4)without uterus
5)bleeding on the day as abnormal bleeding or menstration and excluded by Ob/Gyns
6)Other cases when OB/GYNs decide women should not receive a pap smear by the trained midwives
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tokiko |
| Middle name | |
| Last name | Oishi |
Organization
Takasaki Univ. of Health and Welfare
Division name
Nursing Dpt
Zip code
370-0033
Address
501 Oorui machi, Takasaki city
TEL
027-352-1291
oishi-t@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tokiko |
| Middle name | |
| Last name | Oishi |
Organization
Takasaki Univ. of Health and Welfare
Division name
Nursing Dpt
Zip code
370-0033
Address
501 Oorui machi, Takasaki city
TEL
027-352-1291
Homepage URL
oishi-t@takasaki-u.ac.jp
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
Funding Source
Organization
Grant-in- Aid for scientific research by Japan Society for the Promotion of Science commintioned by MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Takasaki Univ. of Health and Welfare
Address
501 Oorui machi, Takasaki city
Tel
027-352-1291
kuwabara@takasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
206
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 19 | Day |
Last modified on
| 2021 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043185
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
